Difficult AsthmaPRESHNCT01862289
Prevalence of Hyperventilation Syndrome in Difficult Asthma
A study testing Diagnostic of chronic hyperventilation syndrome in people with Difficult Asthma and Severe Persistent Asthma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Most of asthmatics patients remain uncontrolled despite an inhaled steroids treatment. Chronic hyperventilation syndrome (also called Idiopathic Hyperventilation) occurs in 20 to 40% of asthmatic patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult Asthma, Severe Persistent Asthma, Hyperventilation Syndrome
- What is being tested?
- Diagnostic of chronic hyperventilation syndrome
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 1 siteFrance
- Study dates
- 28 Apr 2013to 18 Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- men and women,
- aged more than 18,
- non smokers for two years or longer, less than 10 pack/years smoking history,
- physician-diagnosed asthma,
- uncontrolled asthma with Asthma control test (ACT) < 18,
- historical of FEV1 reversibility,
- daily inhaled steroids treatment by at least 2000microg eq beclomethasone,
- Forced expiratory volume in 1 second (FEV1) > 50% predicted value
Who cannot join
- other chronic pulmonary disease,
- vocal cord dysfunction,
- pregnancy,
- Participation in another interventional research trial,
- unable to provide consent,
- asthma exacerbation within the last 4 weeks
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique - Hôpitaux de Paris, Bicêtre Hospital
Le Kremlin-Bicêtre, 94 275
About this study
Official title: Prevalence of Hyperventilation Syndrome in Difficult Asthmatics Uncontrolled Despite a Daily Maximal Doses of Inhaled Treatment
Most of asthmatics patients remain uncontrolled despite an inhaled steroids treatment. Chronic hyperventilation syndrome (also called Idiopathic Hyperventilation) occurs in 20 to 40% of asthmatic patients. The purpose of the study is to assess the prevalence of chronic hyperventilation syndrome in a specific population of difficult-to-treat asthmatics patients, those who receive daily high doses of inhaled steroids (≥ 1000 µg of fluticasone with an additional treatment by a long-acting beta 2-agonist (LABA) and who remain uncontrolled (Asthma control test (ACT) < 18). We plan to realize a systematic assessment of the diagnosis of chronic hyperventilation syndrome with the Nijmegen questionnaire, blood gases at rest, hyperventilation testing and Cardiopulmonary Exercise Testing(CPET). We also will collect demographic information as well as information about asthma history, asthma control and treatment.
Read the detailed description
There is only one visit. During this visit, each patient will complete self-questionnaires like Nijmegen, Hospital Anxiety and Depression Scale(HAD), Short-Form 36(SF36), and Asthma Quality of Life Questionnaire (AQLQ), The participants will have baseline spirometry and fractional exhaled nitric oxide measured at expiratory flow of 50 mL/s (FENO50), blood gases at rest, an hyperventilation challenge and Cardiopulmonary Exercise Testing(CPET) to determine accurately the presence or not of chronic hyperventilation syndrome. The diagnosis is confirmed by two positive tests (Nijmegen, Hyperventilation challenge and blood gases) and the final decision of a medical committee. The first step is to determine the prevalence oh this syndrome in this specific population. The second step is to assess the sensitivity, the specificity, the false positive rate and the false negative rate of the different parameters measured during the tests.
- Being tested
- Diagnostic of chronic hyperventilation syndrome
- Keywords
- difficult asthma, hyperventilation syndrome, prevalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic of chronic hyperventilation syndromeOther
Also called Exploration to sarch a chronic hyperventilation syndrome
Nijmegen questionnaire, Hyperventilation challenge and blood gases
| Study group | Role | What they receive |
|---|---|---|
| Severe uncontrolled asthma | Experimental | Asthmatics patients with uncontrolled symptoms despite a daily treatment by high doses of inhaled steroids and LABA. Diagnostic of chronic hyperventilation syndrome. Receives: Other: Diagnostic of chronic hyperventilation syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic of the hyperventilation syndrome
value of Nijmegen questionnaire, of blood gases at rest, of hyperventilation testing and of CPET
Measured: Up to 4 hours
Secondary outcomes (4)
Assess the diagnosis value of the nijmegen questionnaire.
Measured: Up to 4 hours
Assess the diagnosis value of the blod gases at rest.
Measured: up to 4 hours
Assess the diagnosis value of the hyperventilation challenge.
Measured: Up to 4 hours
Assess the diagnosis value of the CPET.
Measured: Up to 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study start28 Apr 2013
- Primary completion18 Oct 2016
- Study completion18 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult AsthmaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles Garcia, MD, PhD, Principal investigator, Assistance Publique Hôpitaux de Paris - Bicêtre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862289
- Sponsor's protocol ID
- P110904
- Other IDs
- CRC 11093
- Acronym
- PRESH
- Status last verified
- Apr 2018
- First submitted
- 22 May 2013
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Hyperventilation Syndrome in Difficult Asthmatics Uncontrolled Despite a Daily Maximal Doses of Inhaled Treatment
- ClinicalTrials.gov ID
- NCT01862289
- Acronym / sponsor ID
- PRESH / P110904
- Keywords
- difficult asthma, hyperventilation syndrome, prevalence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 28 Apr 2013 (actual)
- Primary completion
- 18 Oct 2016 (actual)
- Study completion
- 18 Oct 2016 (actual)
- First posted
- 24 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Most of asthmatics patients remain uncontrolled despite an inhaled steroids treatment. Chronic hyperventilation syndrome (also called Idiopathic Hyperventilation) occurs in 20 to 40% of asthmatic patients. The purpose of the study is to assess the prevalence of chronic hyperventilation syndrome in a specific population of difficult-to-treat asthmatics patients, those who receive daily high doses of inhaled steroids (≥ 1000 µg of fluticasone with an additional treatment by a long-acting beta 2-agonist (LABA) and who remain uncontrolled (Asthma control test (ACT) < 18). We plan to realize a systematic assessment of the diagnosis of chronic hyperventilation syndrome with the Nijmegen questionnaire, blood gases at rest, hyperventilation testing and Cardiopulmonary Exercise Testing(CPET). We also will collect demographic information as well as information about asthma history, asthma control and treatment.
Detailed description
There is only one visit. During this visit, each patient will complete self-questionnaires like Nijmegen, Hospital Anxiety and Depression Scale(HAD), Short-Form 36(SF36), and Asthma Quality of Life Questionnaire (AQLQ), The participants will have baseline spirometry and fractional exhaled nitric oxide measured at expiratory flow of 50 mL/s (FENO50), blood gases at rest, an hyperventilation challenge and Cardiopulmonary Exercise Testing(CPET) to determine accurately the presence or not of chronic hyperventilation syndrome. The diagnosis is confirmed by two positive tests (Nijmegen, Hyperventilation challenge and blood gases) and the final decision of a medical committee. The first step is to determine the prevalence oh this syndrome in this specific population. The second step is to assess the sensitivity, the specificity, the false positive rate and the false negative rate of the different parameters measured during the tests.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe uncontrolled asthma | Experimental | Other: Diagnostic of chronic hyperventilation syndromeAsthmatics patients with uncontrolled symptoms despite a daily treatment by high doses of inhaled steroids and LABA. Diagnostic of chronic hyperventilation syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- men and women,
- aged more than 18,
- non smokers for two years or longer, less than 10 pack/years smoking history,
- physician-diagnosed asthma,
- uncontrolled asthma with Asthma control test (ACT) < 18,
Key exclusion criteria (6 listed)
- other chronic pulmonary disease,
- vocal cord dysfunction,
- pregnancy,
- Participation in another interventional research trial,
- unable to provide consent,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic of chronic hyperventilation syndromeAlso: Exploration to sarch a chronic hyperventilation syndromeNijmegen questionnaire, Hyperventilation challenge and blood gases | Other | Severe uncontrolled asthma |
Primary outcome
Diagnostic of the hyperventilation syndrome
Time frame: Up to 4 hours
value of Nijmegen questionnaire, of blood gases at rest, of hyperventilation testing and of CPET
4 secondary outcomes
Assess the diagnosis value of the nijmegen questionnaire.
Time frame: Up to 4 hours
Assess the diagnosis value of the blod gases at rest.
Time frame: up to 4 hours
Assess the diagnosis value of the hyperventilation challenge.
Time frame: Up to 4 hours
Assess the diagnosis value of the CPET.
Time frame: Up to 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Garcia, MD, PhD principal investigator
Assistance Publique Hôpitaux de Paris - Bicêtre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic of chronic hyperventilation syndrome in people with Difficult Asthma and Severe Persistent Asthma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic of the hyperventilation syndrome (time frame: Up to 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2018.